Full System Solutions for Freeze/Thaw Processes
Maintaining product quality, process robustness, reliability, and safety is important for any pharmaceutical product, but the challenges for new biologic treatment and therapies often require a more intensive approach to their preparation, storage, and shipping.
Entegris has established a world-class laboratory dedicated to giving customers access to testing the equipment and containers that will form the foundation of their freeze/thaw process.
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Located at Entegris’ Headquarters in Billerica, Massachusetts, the Technology Center is designed to deliver optimized solutions, address gaps in market access, and has assembled equipment and expertise for optimizing processes to achieve speed to market.
We have established design expertise and a broad component ecosystem, starting with our Aramus™ bag assembly,
to take on your most demanding process challenges like:.
- Product loss
- Cost of ownership
- Security of supply
- Product tracking
- Freeze consistency
- Purity and particulate contamination
- Process validation
Why Visit Our Technology Center?
Informative/instructional visits
- For those new to freeze/thaw or not familiar with the ecosystem
Development showcase visit for engineers or product development
- Showcase upcoming product development and inform design iteration
Freezer demonstrations
- For those new to freeze/thaw or not familiar with the ecosystem
Qualification support
- Too busy to validate? We can create a robust protocol for to sign off and we execute
Customer solution configuration meeting
- Tailoring a solution for the specific problem statement
Virtual visits
- There are webcams and monitors installed in the tech center for virtual walkthroughs
Webinar
Advanced Blast Freezing Technologies for Drug Product Development
Novel therapeutics often rely on advanced blast freezing technologies. This on-demand webinar is an opportunity to improve your understanding of emerging technologies and techniques. Take a deep dive with Entegris and Farrar into biologic bulk drug substance freeze/thaw and integrated solutions, through a cold chain workflow case study with performance data and ROI calculator.
Webinar
Evaluation Criteria of Freezer Systems for Bulk Pharmaceuticals and Intermediates
As shown by the global rollout of the COVID-19 vaccine, the cold chain is a critical part of the pharmaceutical supply chain. How can we make it work better? In this on-demand webinar, presented by BioProcess Online and sponsored by Entegris, we’ll demonstrate:
- Applications for state-of-the art controlled-rate shelf freezers
- The benefits of single-use freezer bags
- Improved scalability, efficiency, sustainability, and process economic optimization
Learn how emerging technologies can make the cold chain safer and more reliable while improving patient outcomes.
Interactive Tool
Cold Chain Guidance
Entegris guides the process of configuring freeze/thaw (F/T) solutions for biologic treatments and therapies based on your specific scenario and needs.
Technology Center Example Studies:
- Define and understand the distribution modes and freeze/thaw equipment infrastructure/path
- Container solution design (bag/shell/shipper)
- Custom bag chamber design validation
- Freeze study
- Freeze/thaw recipe design and verification
- V&Q > ASTM 4169, integrity verification
- E&L and compatibility assessment or services
- Product confirmation (particles, aggregates, titer, etc.)
Applications and Uses
C> treatments such as CAR-T and mRNA vaccine production require repeated freezing and thawing during production. Aramus™ single-use assemblies are ideal for protecting and optimizing cold-chain freeze/thaw processes. With Aramus bag assemblies you can get your C> materials where they need to go.
Aramus Shaped 2D Bags are a key component of cold chain shipping and storage for BDS, API, or C> products. While decentralized processes increase the risks, we can help you manage them. Whether you need -80o or -196oC (-112o or -321oF) we can build bag assemblies and secondary containers that meets your most challenging needs.
High-density cell banking (HDCB) intensifies the upstream process by providing a much larger volume of highly concentrated cells to start a production run. What makes HDCB possible are Aramus shaped 2D bags. Getting the size and fill volume right for intensification allows you to jumpstart your bioreactor, shortening the seed train by several weeks.
Entegris plays a supporting but crucial role in our customers’ efforts to develop and manufacture vaccines including therapies for COVID-19. We have taken several critical steps to bolster supply chains, auditing and validation programs, and have undergone rapid scale-up to meet commercial demand for potential successful candidates in the pipeline.
Featured Content
Aramus™ Bag Assembly Validation Guide
This validation guide addresses key requirements needed to validate Aramus™ bag assemblies for use in regulated applications. It contains sourcing, testing, and regulatory compliance summaries that validate Aramus bag assemblies meet those requirements.
Vendor Partnering in a Bioprocess Manufacturing and Supply Chain Ecosystem
By partnering with a vendor with the expertise and experience to navigate the regulatory paradigm and validate the materials proposed for a process, companies can easily incorporate these newer assemblies in their projects. Entegris can offer its customers a comprehensive approach that addresses the regulatory, clinical, and patient-level challenges inherent to materials selection, leading to the material and performance selections that ensure a treatment’s success, as well as providing the supply chain aspects and security of supply, proper material selection, transparency into certifications for the other fluid contact materials beyond single-use bags.
Webinar | BioPharm International - Optimizing Freeze Thaw Processes for Cell and Gene Therapy Commercialization
Numerous cell and gene therapy workflows rely on the ability of the process to be halted and re-established via freezing and thawing of intermediate and final product formulations. Early process and tool decisions can help overcome future complexity and uncertainty. See how to address freeze/thaw manufacturing capacity and infrastructure challenges by working in partnership with a well-resourced freeze/thaw ecosystem center.
Biomanufacturing Using Single-Use Systems: Fluoropolymer Material Case Study
Presented by: Julien Muzard, field applications technologist EMEA, Entegris
This poster walks through a fluoropolymer material case study and the advantages gamma stable, fluoropolymer single-use technology provide over traditional processes in the biopharmaceutical industry
